The Coalition for Compounding Excellence has put together a new publication aimed at 503A pharmacies, systematically working through every topic in the risk-based audit process with practical tips for staying ahead of the kinds of issues that show up repeatedly during inspections.
The first edition focuses on compounding records and quality control – and covers some common gaps worth checking in your own pharmacy. Are you documenting final preparation traits specifically enough for a checking pharmacist to verify them? Are you weighing discrete dosage forms individually rather than as a group? And are you aware of the final visual inspection requirement tucked into the latest revisions of USP <795> and <797>? If any of those gave you pause, the first edition is worth a read.